Quality Validation Specialist

This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.
Your Role at Baxter
This is where your creativity addresses challenges
The Quality Validation Specialist is a Salaried Non-Exempt position which contributes to our mission of saving and sustaining lives by ensuring the sterilization, calibration and microbial processes align with Corporate and Regulatory Agency requirements by various methods of testing and data analysis.
Your Team at Baxter
Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
What we offer from Day One

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

What you'll be doing

• Schedule, stage and load equipment/supplies with a PIV (Powered Industrial Vehicle) and conduct sterilizer qualification, requalification and evaluation studies
• Collect equipment/supplies and analyze the data provided by the test equipment
• Determine study acceptability
• If any out of limits and exception conditions exist analyze data, material and/or equipment to determine the cause and issue the Exception Report
• Prepare study package for management review and approval
• Review/approve sterilization maintenance requests
• Document calibration results and update computer tracking program
• Conduct calibrations of critical gauges, meters and monitoring devices per specifications or SOP
• Identify and document any out-of-tolerance or exception conditions
• Prepare monthly and quarterly trend reports
• Maintain calibration standard equipment
• Work with outside calibration vendors to include obtaining quotes, making purchase requests and submitting purchase orders
• Package, ship and receive equipment from outside vendors
• Review/approve maintenance and Quality calibration records
• Review exception documents
• Review vendor certifications per applicable CQP's
• Prepare and control bacterial inoculum to be used as a biological indicator for sterilization qualification, requalification and evaluation studies
• Identify and evaluate positive biological indicator units
• Prepare, sterilize and evaluate growth media used in biological indicator testing
• May be designated as an Subject Matter Expert (SME)
• Notify the supervisor and take appropriate action if any safety, quality or discrepancy issues occur
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
• Sustain a clean and safe work area using 6S principles including maintaining and securing provided tools
• Can include working in a Class II, Class III or Class IV Controlled Environment which may include the following dress/gowning requirements: safety glasses, ear plugs, hairnet, beard cover, isolation mask, gown, hood, boots or shoe covers and gloves.
• There is constant or intermittent noise and vibration.
• The air in this environment is typically very warm and humid
• This position involves working around moving equipment

What you'll bring

• High School Diploma, GED or equivalent
• Must be at least 18 years of age
• Must have basic English written and oral communication skills adequate to communicate with other team members
• Must work with and coordinate activity with all levels of management and staff
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
• Must be proficient in the use of computers and software, including but not limited to Microsoft Word and Excel
• Possess or be able to obtain PIV Operator Certification
• Must be able to perform basic mathematics
• Proficient in how to use measurement tools (Caliper, Micrometer, Ruler, etc.) as well as basic hand tools
• Experience in maintenance or sterilization (preferred)
• CRC (Career Readiness Certification) Silver level (preferred)
• Ability to lift and carry up to 50 pounds
• Normal visual acuity and the ability to distinguish color are necessary
• Occasionally specialized PPE is required when working with certain chemicals.
• Must be able to pass the PIV physical
• Must be able to squat, reach above shoulder level, reach at or below shoulder level, twist and bend at the neck, twist and bend at the waist and balance

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $60,000 - $82,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Other Duties as Assigned
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.